Kornimate/medical-research-clean huggingface dataset:
smart study (sellick's maneuver assisted real time) to deliver target cricoid pressure in simulated environment

Conditions: Pulmonary Aspiration of Gastric Contents

Summary: cricoid force is applied during airway management to prevent pulmonary aspiration of regurgitated gastric contents. this force is usually applied by a nurse or anaesthesia assistant. currently this is performed without monitoring and the force applied is determined by the individual's "educated hand" that is derived from his/her experience from past training and practice. studies have shown that the actual force applied by nurse and anaesthesia assistant is inconsistent and deviates from the optimal force. under application of cricoid force results in ineffective cricoid pressure and the risk of pulmonary aspiration. consequences of pulmonary aspiration include lung injury and infection, hypoxia, long intensive care unit stay and even death. over exertion of cricoid force results in distortion of the larynx (leading to difficult bag mask, difficult tracheal tube insertion and hypoxia). preliminary results from previous study (irb 2014/437/d), an observation crossover pilot was carried out comparing the amount of cricoid force applied by 16 nurses on manikin with and without direct feedback. nurses were instructed to apply a range of force of 30-44 newtons on a marked site on the neck region of manikin. a flexiforce load sensor was used. unblinded nurses performed significantly better with feedback using the load sensor then blinded nurses. with funding from a national grant, a real-time measurement of cricoid force is developed to give feedback and guide the operator to exert and maintain the target cricoid pressure during rapid sequence induction (rsi). in this study we aim to verify the sensor system with a manikin and compare the forces applied by nurses with the sensor system and without.

a total of 22 nurses or anesthetists will be recruited inclusion criteria include healthy subjects exclusion criteria include (1) pregnant subjects (2) history of back pain or injury cricoid pressure applied on manikin will be measured 1. by electronic medical grade weighing scale 2. by sensor system electronically

Eligibility criteria:
inclusion criteria: - healthy status exclusion criteria: * pregnant state * history of problems/ surgery to neck or spine.

Keywords: cricoid pressure
a study based on data from german registries that looks at characteristics of people who take the medicine empagliflozin for type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: description of the real-life treatment of adult patients with type-2 diabetes mellitus (t2dm) receiving empagliflozin, comparing the characteristics of patients starting empagliflozin in three time intervals


Eligibility criteria:
inclusion criteria: * at least two outpatient t2dm diagnoses (icd e11.-) in two different quarters and/or at least one inpatient t2dm diagnosis (icd e11) * at least one prescription of an empagliflozin-containing antidiabetic drug: jardiance® (empagliflozin, atc a10bk03, former a10bx12) or synjardy® (empagliflozin/ met¬for¬min, atc a10bd20) exclusion criteria: * any diagnosis of t1dm
magnetic resonance-guided high intensity focused ultrasound for recurrent rectal cancer

Conditions: Recurrent Rectal Cancer

Summary: this pilot study hypothesizes that hyperthermia delivered via magnetic resonance-guided focused ultrasound (mrg-fu) is technically feasible and can be safely used in combination with concurrent reirradiation and chemotherapy for the treatment of recurrent rectal cancer. twenty recurrent rectal cancer patients who are not candidates for surgery will be recruited for hyperthermia treatment delivered via mrg-fu concurrent with reirradiation and oral chemotherapy.

magnetic resonance-guided focused ultrasound (mrg-fu) is a non-invasive, outpatient modality being investigated for the thermal treatment of cancer. in mrg-fu, a specially designed transducer is used to focus a beam of low intensity ultrasound energy into a small volume at a specific target site in the body. mr is used to identify and delineate the tumour, focus the ultrasound beam on the target and provide real-time thermal mapping to ensure accurate heating of the designated target with minimal effect to the adjacent healthy tissue. the focused ultrasound beam produces therapeutic hyperthermia (40-42°c) in the target field causing protein denaturation and cell damage. currently, there is no prospective clinical data reported on the use of mrg-fu in the setting of recurrent rectal cancer. recurrent rectal cancer is a vexing clinical problem. current retreatment protocols have limited efficacy. the addition of hyperthermia to radiation and chemotherapy may enhance the therapeutic response. with recent advances in technology, the investigators hypothesize that mrg-fu is technically feasible and can be safely used in combination with concurrent reirradiation and chemotherapy for the treatment of recurrent rectal cancer without increased side-effects.

Eligibility criteria:
inclusion criteria: * able to give informed consent * weight \<140kg * biopsy-proven recurrent rectal adenocarcinoma * assessed by the treating surgeon, medical oncologist and radiation oncologist, and following a multidisciplinary discussion, determined to have unresectable and/or inoperable disease in the presence or absence of distant metastases * assessed by the treating radiation oncologist and medical oncologist determined to be fit for reirradiation and chemotherapy * prior pelvic radiotherapy * target lesion visible by mr * target lesion accessible for mrg-fu procedure * target lesion maximum dimension ≤ 6cm * able to communicate sensation during mrg-fu treatment exclusion criteria: * abdominal or pelvic surgery (excluding biopsy) ≤ 6 weeks prior to study enrolment * chemotherapy or other systemic anti-cancer agent ≤ 6 weeks prior to enrolment * previous radiotherapy ≤ 6 weeks prior to enrolment * recurrent tumour involves small bowel * unable to characterize pain * pregnant / nursing woman * orthopaedic implant along proposed mrg-fu beam path or at site of target lesion. * serious cardiovascular, neurological, renal or hematological chronic disease * active infection * unable to tolerate required stationary position during treatment * allergy to mr contrast agent or sedation
efficacy, safety and immunogenicity study of sars-cov-2 inactivated vaccine

Conditions: SARS-CoV2 Infection

Summary: this phase iii trial aims to assess the efficacy, safety and immunogenicity of sars-cov-2 vaccine (inactivated) and lot-to-lot consistency evaluation

this trial is randomized, observer-blind, placebo-controlled two arms parallel group, prospective intervention study approximately 1620 subjects aged 18-59 years will be enrolled in this trial for efficacy evaluation. subjects will be divided into 2 treatment arms that are the vaccinated group and placebo group with ratio 1:1. the vaccinated arms will be grouped into three different lot number (lot 1/lot 2/ lot 3) of sars-cov-2 vaccine.

Eligibility criteria:
inclusion criteria: 1. clinically healthy adults aged 18 - 59 years. 2. subjects have been informed properly regarding the study and signed the informed consent form. 3. subjects will commit to comply with the instructions of the investigator and the schedule of the trial. exclusion criteria: 1. subjects concomitantly enrolled or scheduled to be enrolled in another trial. 2. contact with novel coronavirus infected persons (positive for nucleic acid detection) within 14 days prior to the trial. 3. contact to patients with fever or respiratory symptoms surrounding areas or from communities with reported cases within 14 days prior to the trial. 4. two or more cases of fever and/or respiratory symptoms in a small area such as home, office, school and class within 14 days prior to the trial. 5. evolving mild, moderate or severe illness, especially infectious disease or fever (body temperature ≥37.5℃, measured with infrared thermometer/thermal gun). 6. the result of rt-pcr of swab nasopharyngeal is positive 7. reactive igg and igm for sars-cov-2 (by standardize rapid test). 8. women who are lactating, pregnant or planning to become pregnant during the study period (judged by self-report of subjects and urine pregnancy test results). 9. history of asthma, history of allergy to vaccines or vaccine ingredients, and severe adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema. 10. history of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection. 11. patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which according to the investigator might interfere with the assessment of the trial objectives. 12. subjects who have any history of confirmed or suspected immunosuppressive or immunodeficient state, or received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulins, blood-derived products or long-term corticosteroid therapy (\> 2 weeks)). 13. subjects who have history of uncontrolled epilepsy or other progressive neurological disorders, such as guillain-barre syndrome 14. subjects receive any vaccination within 1 month before and after ip immunization. 15. subjects plan to move from the study area before the end of study period.

Keywords: vaccine sars-cov-2 infection
effects of a platelet transfusion best practices alert

Conditions: Thrombocytopenia

Summary: this study is to determine the effectiveness of a computerized clinical decision support tool (best practice alert - bpa) in reducing unnecessary platelet transfusions based on guidelines published by national transfusion societies such as the aabb (formerly american association of blood banks).

a computerized alert will be deployed through the electronic health record. the alert will trigger when a provider orders platelet transfusion above a threshold supported by current guidelines. the alert will provide information on current evidence and give the provider the option to cancel the order or proceed. the alert will not be triggered in procedural areas such as the operating room or as part of any emergency orders to prevent any delays to urgent patient care. the proposed project will evaluate this alert by randomizing its implementation by patient chart. the investigators will observe the prevalence of this alert and its impact on ordering practices for the next 3 months. for patient charts randomized not to receive the intervention, the providers will not receive any alerts, but the analytics tool will record if the alert would have been triggered and the pertinent clinical information. after a period of three months, the investigators will review patient and provider information through analytics tools, assessing differences in platelet usage between the patients whose charts showed the alerts vs. those (control) patient charts not showing alerts.

Eligibility criteria:
inclusion criteria: * recent platelet count \>50k/ul * platelet transfusion ordered exclusion criteria: * neurosurgery * procedure area (or, catheterization lab, interventional radiology suite) * documented history of antiplatelet agent

Keywords: electronic health records best practice alerts
effect of corona virus on intravitreal injections

Conditions: Diabetic Macular Edema; Age-Related Macular Degeneration; Choroidal Neovascularization; Myopic Choroidal Neovascularisation; Diabetic Retinopathy

Summary: during pandemic of corona virus, patients compliance may be affected. we aim to study the factors lead to unregulated visits and its implications on the final visual outcome.

the corona virus pandemic may affects patients regular visits to ophthalmic clinic, we aim to study the sequel of the pandemic on intravitreal injections results in diabetic macular edema, wet age related macular degenerations, myopic choroidal new vascularization, and proliferative diabetic retinopathy.

Eligibility criteria:
inclusion criteria: * patients with the following conditions (diabetic macular edema, wet age related macular degeneration, myopic choroidal new vascularization and retinal vein occlusion complicated with macular edema). exclusion criteria: * patients that are known to have hypersensitivity to anti-vegfs.
safety of lopinavir/ritonavir (kaletra) in hiv/hcv co-infected subjects vs baseline liver biopsy metavir score

Conditions: HIV Infection

Summary: the purpose of this study is to evaluate clinical response and safety of a kaletra containing antiretroviral treatment regimen in hiv positive subjects with hcv coinfection.


Eligibility criteria:
inclusion criteria: * documented hiv positive. * at least 18 years of age. * does not exhibit evidence of acute illness (especially any acute liver disease, except hepatitis c) * subject has not been treated for an active opportunistic infection within 30 days of the baseline visit. * subject has a karnofsky score greater than or equal to 70. * subject does not require and agrees not to take, for the duration of the study, any of the following medications that are contraindicated with kaletra: astemizole, terfenadine, midazolam, triazolam, cisapride, certain ergot derivatives (ergotamine, dihydroergotamine, ergonovine, and methylergonovine), pimozide, propafenone and flecainide. rifampin, a potent enzyme inducer, should not be administered with the study medication, because of the possibility of significant decreases in kaletra concentration during concurrent administration. * the subject agrees not to take any medication, including over-the-counter medicine, alcohol, recreational drugs or herbal preparations without the knowledge and permission of the principal investigator. * subject had laboratory testing within the previous three months and the most recent testing demonstrates all of the following: hemoglobin\> 8.0 g/dl; absolute neutrophil count \> 750 cells/ml; platelet count \> 20,000/ml; alt or ast \</=10 x upper limit of normal (uln); creatinine\< 1.5 x uln; triglycerides \</=750 mg/dl. * subjects have no evidence of grade iii or iv adverse event or laboratory abnormality (except for lfts). exclusion criteria: no exclusion criteria.

Keywords: lopinavir ritonavir phase 4 hiv
the effect of two exercise training protocols on physiological and biochemical parameters in congestive heart failure

Conditions: Heart Failure

Summary: the aim of the present study is to evaluate differential lactate removal kinetics in heart failure patients that are trained according to 2 different exercise protocols: (a) high intensity intervals training (hit); (b) continuous moderate aerobic training (mat)

introduction: congestive heart failure (chf) patients suffer from early fatigue and functional aerobic impairment. their reduced cardiac output and o2 delivery to the peripheral muscles shifts those patients consistent anaerobic metabolism, thus, chf patients rely on anaerobic metabolism even in everyday life activity. this metabolism leads to a shift of muscles fiber types from mainly slow twitch, oxidative type i fibers to fast twitch, glycolytic type iib fibers. monocarboxylate proteins mct1 and mct4 transport lactate crosses the membrane. mct1 is responsible for the lactate uptake and mct4 is responsible for efflux of excess lactate. exercise training is known to improve the quality of life in chf. we hypothesized that exercise training might change mct1 and 4 expression and distribution. accordingly, these changes may also affect lactate clearance during recovery, which may contribute to the beneficial effect of exercise training in chf patients. methods: new-york heart association (nyha) class ii-iii chf patients will be assigned to the experiment. at baseline and upon training conclusion they will undergo the same tests battery. the test battery includes heart rate, blood pressure measurements, echocardiographic evaluation. all participants will fill out "minnesota living with heart failure" questionnaire. subsequently, after their basal blood lactate will be assessed they will undergo measurement which will be followed by lactate clearance-rate evaluation. randomly each patient will then be assigned to one of two experimental training groups: (a) high intensity intervals training (hit); (b) continuous moderate aerobic training (mat). each volunteer will be trained twice a week for 12 weeks, according to his/hers assigned training protocol and in accordance to exercise training guidelines.

Eligibility criteria:
inclusion criteria: * stable heart failure patients referred to exercise training in a tertiary care cardiac rehabilitation institute * age \> 21 exclusion criteria: * severe symptomatic heart failure * severe orthopedic limitations * unstable arrythmia * cognitive decline or substance abuse * unable to comply with exercise protocol * significant pulmonary disease * nyha 4 heart failure class

Keywords: rehabilitation exercise training interval training
a cohort study to evaluate immunogenicity for chinese children at the time of clinical pneumonia diagnosis

Conditions: Immunogenicity, Vaccine

Summary: this is a pac study after pcv13 launch in china. based on recommendation from china agency, pfizer was required to conduct a descriptive immunogenicity study to measure the antibody levels at the time of disease onset.


Eligibility criteria:
inclusion criteria: 1. evidence of a personally signed and dated informed consent document indicating that the parent(s)/legal guardian has been informed of all pertinent aspects of the study. 2. subjects whose caregiver is willing and able to comply with scheduled visits, laboratory tests, and other study procedures. 3. a diagnosis of clinical pneumonia per sch standard of care. 4. 5 months to ≤60 months of age at the time of consent. 5. vaccination history (ie, vaccine book or picture of vaccine book) is available for confirmation. exclusion criteria: 1. infant or child who is a family member of: * investigator site staff members directly involved in the conduct of the study; * site staff members otherwise supervised by the investigator; * pfizer employees directly involved in the conduct of the study. 2. other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 3. blood draw is counter indicated. 4. previous participation in this study within 30 days. 5. previous vaccination with licensed or investigational pneumococcal vaccine. this excludes previous vaccination with 13vpnc as per the approved recommendations in china. 6. received blood, blood fractions, plasma, or immunoglobulins within 3 months of the study blood draw. 7. hospital acquired pneumonia (ie, onset \>48 hours after hospitalization).

Keywords: serum concentrations of anticapsular immunoglobulin g (igg) and serum levels of opsonophagocytic activity (opa) for the pcv13 pneumococcal serotypes
immunological profile and clinical characteristics of children diagnosed with chronic granulomatous disease

Conditions: CGD

Summary: immunological profile and clinical characteristics of children diagnosed with chronic granulomatous disease

cgd "chronic granulomatous disease is a rare genetically determined disorder aﬀecting the immune system characterized by recurrent and persistent bacterial and fungal infections due to the inability of the body's phagocytic cells (neutrophil and monocytes) to kill certain phagocytosed microorganisms.). cgd is caused by mutations in one of the ﬁve genes coding for nadph(nicotinamide adenine dinucleotide phosphate ) oxidase subunits. approximately 70% of cases are caused by mutations in the cybb gene leading to x-linked cgd, which often causes a severe form of the disease. more than 700 pathogenic mutations in the cybb gene encoding the gp91-phox protein have been documented. other biallelic mutations in cyba, ncf1, ncf2, and ncf4 cause autosomal recessive cgd. in addition, a novel er-resident transmembrane protein called eros (essential for reactive oxygen species) that is essential for the regulation of nadph oxidase and controls the phagocyte respiratory burst was described. a homozygous cybc1/eros mutation was associated with the development of cgd symptoms usually start in infancy or early childhood. patients with the x-linked form of cgd (60-70% of patients) tend to present earlier and have more severe disease than patients with autosomal recessive forms. most x-cgd develop failure to thrive,recurrentbacteriallymphadenitis and pneumonia due to catalase-positive organism especially staphylococcus, also skin, liver,and other internal organs abscesses, and osteomyelitis. in addition, cgd patients are more subjected to invasive lifethreatening fungal infections that aﬀect the lungs and bones. another problem with patients diagnosed with cgd is the excessive inﬂammatory reactions leading to granulomatous lesions that typically aﬀects the bladder and gastrointestinal tract. the primary diagnostic tests used in cgd functionally assess the nadph complex in stimulated neutrophils.the dihydrorhodamine (dhr) assay is the gold standard for diagnosing cgd. to the investigator's knowledge this will be the first study in assiut university children's hospital to discuss the clinical characteristics and immunological profile of pediatric patients diagnosed as cgd in assiut university children's hospital. in fact there is defect in data about cgd in upper egypt .

Eligibility criteria:
inclusion criteria: age at enrollment less than18 years. both genders. diagnosed as probable cgd. exclusion criteria: children above 18 years old. children not fullfilling the criteria of cgd